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Packaging / Food science / Hygiene / Barrier isolator / Pharmacy / Industrial engineering / Aseptic processing / Aseptic technique / Form FDA 483 / Health / Pharmaceutical sciences / Technology


Unique Pharmecutical, Ltd - Outsourcing Facility
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City

Dallas / /

Company

Unique Pharmaceutical Ltd / SS Unique Pharmaceutical Ltd / /

Facility

JNTRY TYl'e ESTASUSHMENT INSPECTED Temple / iMENT INSPECTEO Temple / B Complex / North Central Expressway / 1NSP£CTEO Temple / /

/

IndustryTerm

rubber stoppers / contamination ofthe drug product / release ofdrug product / deficient regarding systems / drug product / human drug products / aseptic manipulation ofdrug products / aseptic processing areas / media fills / rubber vial stoppexs / closure systems / aseptic processing / pharmacy technicians processing drug products / steel trays / proces.-;ing ofdrug products / human drug product / drug products / aseptic processing area / /

Organization

PAGES DEPARTMENT OF HEAI / FDA / DEPARTMENT OF HEALTH AND HUMAN SERVICES / /

Person

Scott T Ballard / Darla J. Christopher / Daniel Volney / Danie / Ste / Darla J. Chri / FEI NUM BI / /

/

Position

Investigator / portion ofthe technician / Chief Executive / Chief Executive Officer / General / technician / Officer / Director / same technician / representative / pharmacy technician / Director ofQuality / Chief / /

Product

Glycopyrrolate / Promethazine / fS / Sodium Bicarbonate / Dextrose / Oxytocin / Bacitracin / Calcium Chloride / Lidocaine / Lansoprazole / Nystatin / Dexamethasone Acetate / Tnt / Ondansetron / /

ProvinceOrState

Texas / PAGES DEPARTMENT OFHEALm AND HUMAN SERVICES FOOD AND DRUO ADMINJSTRATION DiSTRICT / DEPARTME.t'IT OF HEALTH AND RUMAN SERVICES FOOD AND DRUG AOMINISTRATION DISTRICT / /

RadioStation

WHOM / /

Technology

artificial intelligence / /

URL

www.fda / www.fda.gov/oc/industry / /

SocialTag